Showing all posts written by Douglas Wentzel
Doug graduated from Drexel University, summa cum laude, with a bachelor's degree in Civil Engineering. While an undergraduate, he acquired structural engineering industry experience and designed structural members for various high-rise buildings and mechanical systems. Additionally, Doug collaborated in designing an 18-story addition to a university dormitory. Among other projects, he has also fabricated a custom forced induction system for a naturally aspirated automobile.
Doug received his J.D. from the University of Pennsylvania Law School, where he founded a program to help engineering students incorporate intellectual property considerations into their hypothetical start-up businesses.
Doug worked as a summer associate at the firm in 2014 and 2015 and joined the firm in 2016.
Developments in Patent Disputes Between Apple and AliveCor
Earlier this year, AliveCor, Inc., a medical device and AI company producing electrocardiogram (ECG) hardware and software for consumer mobile devices, succeeded in convincing an International Trade Commission (ITC) judge that Apple Inc. infringed multiple, valid claims of three AliveCor patents on ECG technology. By December 12, 2022, the full ITC is expected to issue a final decision in that investigation (337-TA-1266).
With the final ITC decision just days away, Apple filed suit against AliveCor, Inc. in the Northern District of California on December 2. Apple alleges that the ECG functionality of several AliveCor products, including KardiaMobile, KardiaMobile 6L (pictured below), KardioMobile Card, and the related Kardia App, infringe one or two Apple patents: U.S. Patent Nos. 10,076,257 and 10,866,619. Apple also alleges that AliveCor’s KardiaPro service and Kardia App, in conjunction with various Kardia devices, infringe one or two additional patents: U.S. Patent Nos. 10,270,898 (titled “Wellness Aggregator”) and 10,568,533 (titled “User Interfaces for Health Monitoring”).
Less than a week after Apple filed suit, a panel of Patent Trial and Appeal Board (PTAB) administrative judges found that the three AliveCor patents asserted in the ITC investigation were invalid. According to Law360, an AliveCor spokesperson explained AliveCor is “deeply disappointed and strongly disagrees with the decision by the PTAB and will appeal.” Regarding whether the PTAB’s findings should impact the ITC’s decision, the AliveCor’s spokesperson added:
The PTAB and ITC are two, separate independent bodies and will make their own separate independent decisions. We look forward to the separate final determination from the ITC expected December 12 and are cautiously optimistic.
Apple Watch Found to Infringe AliveCor ECG Patents
AliveCor, Inc., a company focused on cardiac data and remote medicine, successfully convinced an International Trade Commission (ITC) judge that Apple, Inc. infringed multiple AliveCor patents related to electrocardiogram (ECG) technology. AliveCor asserted that the Apple Watch (Series 6 and 7) infringes multiple AliveCor ECG patents and seeks to ban the watches from importation into the U.S.
In a June 27, 2022 Notice of Initial Determination, an ITC Administrative Law Judge (“ALJ”) agreed with AliveCor, determining Apple had violated Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337), related to “Unfair practices in import trade.” The ALJ found the ECG functionality of the Apple Watch Series 6 and Series 7 (pictured below) infringed multiple, valid claims of two AliveCor patents: U.S. Patent Nos. 10,638,941 (titled “Discordance Monitoring”) and 10,595,731 (titled “Methods and Systems for Arrhythmia Tracking and Scoring”).
AliveCor is the complainant in ITC Investigation No. 337-TA-1266 (the “1266 Investigation”), captioned Certain Wearable Electronic Devices with ECG Functionality and Components Thereof. A public version of the ALJ’s complete Initial Determination should be released soon. By October 26, 2022, the full ITC is expected to issue a final decision in the 1266 Investigation. If the Commission affirms the ALJ’s findings, the Apple Watch Series 6 and Series 7 could be banned from importation into the United States.
Boston Scientific To Acquire Blood Clot Removal Tech Company Devoro Medical
Boston Scientific Corp. has agreed to acquire Devoro Medical Inc. in a deal expected to close this year. Boston Scientific previously held a 16% equity stake in Devoro Medical and now agrees to acquire the remaining 84% stake for $269M. Boston Scientific also agrees to pay up to $67M more if Devoro Medical clears certain regulatory and clinical milestones.
Devoro Medical is the developer of the WOLF Thrombectomy® Platform–a technology platform that “targets and rapidly captures blood clots using finger-link prongs that retrieve and remove thrombi in the arterial and venous systems.”
According to Boston Scientific’s press release:
“The addition of the WOLF platform advances our efforts to ensure physicians have the right tools to improve procedural efficiencies,” said Jeff Mirviss, executive vice president and president, Peripheral Interventions at Boston Scientific. “Clot management remains a core focus of our business, and upon commercialization, this highly differentiated technology will complement and expand our offerings to a full suite of interventional strategies for thromboemboli, which also includes the EkoSonic™ Endovascular System (EKOS) and the AngioJet™ Thrombectomy System.”
Boston Scientific plans to accelerate development of the WOLF platform following its acquisition of Devoro Medical, according to Michael R. Jaff, D.O., its Chief Medical Officer and Vice President of Clinical Affairs, Technology and Innovation, Peripheral Interventions.
This deal is the latest in a series of acquisitions this year by Boston Scientific. In January, Boston Scientific agreed to acquire cardiac wearables company Preventice Solutions for $925M. In March, Boston Scientific agreed to acquire the global surgical business of Lumenis LTD for $1.07B. And, in June, Boston Scientific agreed to acquire cardiac ablation device maker Farapulse for $295M.
Stryker to Acquire Surgical Smoke Evacuator Company SafeAir
Stryker recently announced an agreement to acquire SafeAir AG, a Swiss surgical smoke evacuation company. The acquisition will likely close by the end of 2018.
According to its website, SafeAir specializes in smoke evacuating diathermy pencil products. Diathermy pencils are used in electrosurgical procedures such as cauterization. Such procedures generate smoke, and SafeAir’s Smoke Pencil products have an integrated smoke evacuation function to remove such surgical smoke from its source.
Timothy J. Scannell, Group President of MedSurg and Neurotechnology at Stryker, sees value in the acquisition, stating that:
The acquisition of SafeAir AG is highly complementary to the Surgical business of Stryker’s Instruments division , and strengthens our smoke evacuation portfolio in both the U.S. and Europe.
Regarding how this acquisition fits into Stryker’s medical device portfolio, Mr. Scannell went on to report:
This acquisition aligns with Stryker’s focus of providing solutions that result in a higher quality of care and level of safety for both healthcare professionals and patients.
Stryker’s forthcoming acquisition may indicate the company’s understanding of the growing smoke evacuation system market that is expected to grow at a compound annual growth rate of 5.6% and reach $180M within 18 months.
Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software
3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D printer at the point-of-care. The physical models created with Mimics inPrint assist practitioners with patient diagnostics, consultation, and planning complex procedures. According to a company press release, Mimics inPrint is already used by 16 of the top 20 hospitals to provide personalized patient care at the point-of-care.
In the press release, Materialise CEO Wilfried Vancraen stated:
Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world. The FDA clearance for our Mimics inPrint software will support the adoption of 3D planning and printing in U.S. hospitals and the creation of point-of-care 3D printing facilities.
According to Frank J. Rybicki, MD, PhD and Chief of Medical Imaging at Ottawa Hospital:
This milestone for Materialise serves as a benchmark for the clinical implementation of 3D printing for physicians creating 3D models at the point-of-care.
Materialise describes itself as having 27 years of 3D printing experience and according to USPTO public database records is currently the assignee of 34 issued patents and 106 patent applications dating from 2004 to the present.
FDA Issues Final Guidance on Software as a Medical Device
The FDA continues to address items on its Digital Health Innovation Action Plan. After recently issuing proposed guidance and a pilot program relevant to Software as a Medical Device (“SaMD”), the FDA issued a final guidance regarding SaMD on December 8, 2017. The guidance adopts a set of quality management principles relevant to “software that utilizes an algorithm (logic, set of rules, or model) that operates on data input (digitized content) to produce an output” such as informing, diagnosing, or treating a patient.
In a press release announcing the final guidance, FDA Commissioner Scott Gottlieb stated:
This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product. . . . [W]e’re issuing new details on the common principles we and our international partners will use for evaluating the safety and effectiveness of SaMD.
The principles referred to by Commissioner Gottlieb include the following SaMD Quality Management Principles:
- An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD;
- A set of SaMD lifecycle support processes that are scalable for the size of the organization and are applied consistently across all realization and use processes; and
- A set of realization and use processes that are scalable for the type of SaMD and the size of the organization; and that takes into account important elements required for assuring the safety, effectiveness, and performance of SaMD.
Commissioner Gottlieb further opined that this guidance and the IMDRF principles within it “provide [the FDA] with an initial framework when further developing [the FDA’s] own specific regulatory approaches and expectations for regulatory oversight.”
Testing of Jenex TherOZap™ Device Set to Begin
Luminar Media Group recently announced that, after completing development of a working prototype device, the Jenex Corporation has signed an agreement with the Techna Institute at the University Health Network to begin testing the TherOZap™ device’s efficacy against the West Nile and Zika viruses.
The Jenex Corporation describes itself as a progressive medical technology company involved in the creation of an array of dermatological medical device products. Aside from TherOZap™, Jenex’s website indicates that it currently markets the Intercept CS device which is said to prevent cold sore outbreaks using the device’s thermal heat conductivity.
Jenex and the Techna Institute are developing a series of protocols for the initial testing of the TherOZap™ device. Regarding the current stage of development of the device, Rob Fia, CEO of the Jenex Corporation, stated:
We are pleased to test our patent pending TherOZap™ technology against both the Zika and West Nile virus’ especially given the wide spread of the Zika virus around the world. Jenex has engaged a world-renowned lab to initiate testing of the technology to determine if it can be effective in inactivating the virus. We look forward to providing an update on the initial results of the tests in the near future.